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Medicines/pharmaceuticals of animal origin V3.0 November 2020

Medicines/pharmaceuticals of animal origin - This guideline provides information for all clinical staff within Hospital and Health Services (HHS) on best practice for avoidance of issues related to animal products.

Medicines/pharmaceuticals of animal origin - V3.0 November 2020

Published by the State of Queensland (Queensland Health), November 2020 This document is licensed under a Creative Commons Attribution 3.0 licence.

To view a copy of this licence, visit creativecommons.org/licenses/by/3.0/au © State of Queensland (Queensland Health) 2020 You are free to copy, communicate and adapt the work, as long as you attribute the State of Queensland (Queensland Health).

For more information contact: Services Queensland, Queensland Health, GPO Box 48, Brisbane QLD 4001, email [email protected] An electronic version of this document is available at https://www.health.qld.gov.au/__data/assets/pdf_file/0024/147507/qh-gdl-954.pdf

Disclaimer: The content presented in this publication is distributed by the Queensland Government as an information source only. The State of Queensland makes no statements, representations or warranties about the accuracy, completeness or reliability of any information contained in this publication. The State of Queensland disclaims all responsibility and all liability (including without limitation for liability in negligence) for all expenses, losses, damages and costs you might incur as a result of the information being inaccurate or incomplete in any way, and for any reason reliance was placed on such information.

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Table of Contents

1 Purpose 4

2 Scope 4

3 Background 4

4 Religious restrictions 5 4.1 Organisations consulted: 7

5 Resources 7

6 Appendices 9 Appendix A - Porcine (Pig) products 9 Appendix B - Bovine (Cow) products 11 Bovine – Manufacture includes exposure to bovine materials “Bovine-Indirect 14 Appendix C Chinese Hamster Ovary (CHO) cells 17 Appendix D - Murine (mouse) 21 Appendix E - Equine (Horse) 25 Appendix F - Egg/Chicken 26 Appendix G – Other Animals 29 Appendix H - Excipients that may be of animal origin 31

7 References 32

8 Approval 33

9 Version Control 33

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1 Purpose

This guideline provides information for clinicians to assist patients wishing to avoid animal product, to make informed decisions about their treatment/care.

2 Scope

People with food allergies or intolerances, or who want to avoid animal products for religious, cultural or secular reasons may want to know about the origin/source of drugs and excipients contained within their medicines, to enable them to make a fully informed decision about their treatment. This wish is supported by the Australian Charter of Healthcare Rights which states that ‘patients have a right to have their culture, identity, beliefs and choices recognised and respected’. This document provides information for clinicians to assist patients in making this choice. This guideline provides information for all clinicians involved in the medicines management cycle within Hospital and Health Services (HHS). While the information contained in the tables of products in the appendices is compiled from the best information available, it should not be regarded as fully comprehensive. Information on enteral and infant feeds (and many herbal and complimentary medicines) is not included in this document. Please refer to a dietitian for advice on enteral/infant feed composition.

3 Background

Person-centred care is the gold standard approach to healthcare delivery and has been shown to improve the safety and quality of health care, improve patient outcomes and experience, and improve the performance of health service organisations1. For this reason, healthcare professionals must take into consideration patients’ patients’ religious beliefs and lifestyles when prescribing and administering medicines.2 Many different medicines and , or specific formulations of a medicine such as tablets, capsules, creams or mixtures contain animal products or are animal derived. For example, gelatin is a partially hydrolysed collagen which is usually bovine (beef) or porcine (pig) in origin. Gelatin is used in making capsule shells and is one of many types of stabilisers added to pharmaceutical products such as vaccines.3 Heparin, an injectable anticoagulant, is prepared from a porcine source. Further examples of pharmaceutical products known to be of animal origin are listed in the appendices Several of the world’s most prominent religions have objected to the use of certain animal- derived products, including Muslim, Hindu, Christian, Jewish and Buddhist faiths (see table 1). A growing number of individuals are also increasingly restricting their consumption and use of animal-derived products for ethical reasons such as animal welfare and objections to the intentional killing of animals, environmental concerns and perceived health benefits, However, neither religious nor secular groups are homogeneous in their views on the use of

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animal-derived products used in their care. Consequently, there is considerable diversity of opinion, and membership of a particular group does not necessarily dictate an individual’s convictions4. However, informing patients about the origins of their proposed medication (if animal derived and no suitable synthetic alterative exists) will assist them in making informed decisions regarding their treatment.2 There may be provisions within various religious groups to provide some form of dispensation, depending on the nature of the need for treatment.

NB All medicines must undergo testing in non-human animals before they can proceed to testing in humans in order to gain a product license13.

4 Religious restrictions

Table 1 Religious restrictions

Countries where widely Religion practiced (relevant to Restrictions Queensland)

Tibet, Bhutan, , Nepal, Sri Lanka, Burma, Thailand, Laos, For some vegetarian Buddhists - all Buddhism Cambodia, Malaysia, Vietnam, China, animal products prohibited Bangladesh, Korea, Japan, however, no fixed rules. Singapore, parts of Russia.

For majority who are vegetarian – India, Nepal, Bangladesh, Indonesia, all animal products including egg Pakistan, Sri Lanka, Philippines, Fiji, prohibited Hinduism UK, Mauritius, Bhutan, , For those who are not vegetarian, Burma, Singapore restrictions still include bovine* and porcine products

Porcine products prohibited Indonesia, India, Pakistan, All animal products not killed in Bangladesh, , Turkey, Iran, the prescribed ritualistic way Nigeria, Ethiopia, Afghanistan, (halal) prohibited Islam Sudan, Iraq, Malaysia, Tanzania, Products containing alcohol Somalia, Cote d’Ivoire, Congo, prohibited Philippines, Sierra Leone, Thailand, Please note gelatin is Eritrea, Lebanon contentious**

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Countries where widely Religion practiced (relevant to Restrictions Queensland)

Jehovah’s Abstain from products e.g. witnesses blood transfusions. [The use of fractions derived from the A 24 hours a day primary components of blood is not service for absolutely prohibited see – religious and clinicians treating ethical position medical therapy] Jehovah’s Australia, USA, , and Witnesses is many other countries (240 in total) Queensland Blood Management available. The number can be provide information on consent found via the and refusal see: consent-refusal ‘Contacts’ Button on their site Many HHSs have procedures for refusal of blood products.

All porcine and shellfish products prohibited Other rules about animal products that can be ingested: • land animals must be mammals which chew their cud and have cloven hooves USA, Israel, France, Canada, UK, • Judaism Russia, Argentina, Ukraine, Brazil birds of prey are prohibited and South Africa • fish must have fins and scales • non-fish seafood is prohibited e.g. shellfish • meat and milk (any dairy) cannot be mixed Observers only consume kosher products – complex set of rules

Seventh Day Australia, USA, South America, some Some abstain from meat, but eggs Adventist African countries are permissible.

For some who are vegetarian – all animal products including egg prohibited For those who are not vegetarian, India, Pakistan, Malaysia, Singapore, restrictions still include bovine and Sikh Fiji, New Zealand, USA and UK porcine products All animal products from halal sources prohibited Products containing alcohol prohibited.

Adapted from Multicultural Clinical Support Resource Folder- Health and Religion available at https://www.health.qld.gov.au/__data/assets/pdf_file/0025/158740/8mcrs_hlth_relgn.pdf accessed 03/08/2020

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4.1 Organisations consulted:

• Buddhist Council of Queensland (President) • Hindu Society of Queensland (President) • Brisbane Sikh Temple (President) • Seventh-day Adventist Church South Queensland (President) • Jehovah’s witnesses Hospital Information Services International Office • The Islamic Council of Queensland (Secretary) • Vegan Australia • Queensland Jewish Board of Deputies Incorporated

5 Resources

A United Kingdom publication titled “Drugs of porcine origin and their clinical alternatives - An introductory guide” 2 (written in 2004, accessed 26/08/2020) gives further information on drugs of porcine origin and is available at: http://archive.mcb.org.uk/wp- content/uploads/2015/12/Drugs-Derived-From-Pigs-and-their-Clinical- Alternatives_Booklet.pdf A Canadian question and answer document produced by the Alberta Health Services – Calgary provides healthcare professionals with an introduction to the religious and cultural issues associated with drugs of animal origin and the need for informed choice in a multicultural society.5 This document, titled “ derived from animals and culturally diverse patients” is available at: https://www.albertahealthservices.ca/assets/programs/ps-1026227-health-care-religious- beliefs.pdf The Vegan society (England and Wales) has two blogs about medication: Is my medication vegan? available at: https://www.vegansociety.com/whats-new/blog/my- medication-vegan and What vegans should know pre-operatively available at: https://www.vegansociety.com/whats-new/blog/what-vegans-should-know-pre-operatively The manufacturer’s Product Information (PI) gives details on the composition of the medicine (i.e. listing the active and inactive constituents/ingredients) and provides some form of description on how the medicine is produced (e.g. whether manufacture of the product included exposure to animal derived materials). Also, Consumer Medicine Information (CMI) leaflets are available for most prescription medicines which enable patients to check the medicine’s ingredients. However, these leaflets are produced in English only, so further assistance may be needed. There appears to be no consistently practical way of identifying whether the gelatin in products has come from beef or pork. This information is not always stated in manufacturers’ PI or CMI leaflets but may be important for Jewish, Muslim and Hindu people who may want to avoid even traces of these particular animal products. If patients are concerned about whether the drug or excipients within their medicine are of animal origin,

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they could seek the information from their pharmacist or doctor who can check the medicine's PI or CMI. Alternatively, patients can call the National Prescribing Services (NPS) Medicines Line (1300 888 763)6 or contact the Medical Information Department of the pharmaceutical company that makes the medicine7. For further clarification, the patient could seek guidance from their religious organisation.

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6 Appendices

Appendix A - Porcine (Pig) products

Product name Generic name Therapeutic class Comment

Anticoagulant, derived from porcine Clexane Enoxaparin Antithrombotics intestinal mucosa

Digestive Pancreatic extract Creon Pancrelipase supplements and (porcine) cholelitholytics

Digestive Creon Micro Enteric Pancreatic extract Pancrelipase supplements and coated granules (porcine) cholelitholytics

natural porcine lung Curosurf Poractant alfa Respiratory agent surfactant

Herbal Ethical Nutrients gastrointestinal pepsin (porcine) Digestion plus preparations

Fragmin Dalteparin Anticoagulant pig mucosa

porcine parvovirus Normal (PPV) as a model for Gamunex immunoglobulin Immunoglobulin human parvovirus (Human) B19

Heparin sodium Heparin sodium Anticoagulant Porcine mucous injection

Heparinised saline Heparin sodium Anticoagulant Porcine mucous

Heparinised saline Heparin sodium Anticoagulant Porcine mucous injection

Porcine pseudorabies Imogam Rabies Rabies immune Rabies immune was selected to Pasteurized globulin (human) globulin (human) model hepatitis B virus and herpes virus

Measles, mumps and M-M-R II Powder for rubella virus Vaccine Porcine gelatin injection live

Obizur Haemostatic agent Porcine sequence

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Product name Generic name Therapeutic class Comment

From animal mucosa Orgaran Danaparoid Haemostatic agent (Porcine)

Amylase, Lipase, Digestive Pancreatic extract Panzytrat 25000 Pancrelipase, supplement (porcine) Protease

Human prothrombin Prothrombinex-VF Haemostatic agent Heparin, porcine complex

Measles, Mumps, hydrolysed porcine ProQuad Rubella and Varicella Vaccine gelatin Virus Vaccine Live

Contains porcine Human rotavirus live Rotarix Vaccine circovirus type 1 attenuated vaccine (PCV-1)

Rotavirus vaccine porcine circoviruses RotaTeq Vaccine live oral pentavalent (PCV) 1 and 2

Varivax Refrigerated hydrolysed porcine Live varicella vaccine. Vaccine Powder for injection gelatin

Zoster virus vaccine hydrolysed porcine Zostavax Vaccine live gelatin

Appendices A to G compiled from reference 9

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Appendix B - Bovine (Cow) products

Product name Generic name Therapeutic class Comment

Artiss contains synthetic . As synthetic Aprotinin (synthetic), aprotinin is factor XIII, structurally identical Surgical antiseptics Artiss , to bovine aprotinin, and applications and calcium chloride the use of Artiss in dihydrate patients with allergies to bovine proteins should be carefully evaluated

Benadryl Children's Herbal respiratory lactoferrin - bovine

Cough 2 years + preparation (from cow's milk)

bovine lactoferrin Iron – vitamin and BioHeme (derived from cow's mineral milk)

Blackmores Lactoferrin, bovine Immunodefence Immune supplement (dairy) capsules

Blackmores Joint Formula, Joint Herbal analgesics Formula Advanced & Chondroitin sulfate and anti- Joint Formula bovine inflammatories Advanced with MSM Booster

Herbal analgesics Chondroitin sulfate ChondroCare Excel and anti- bovine inflammatories

Herbal analgesics Chondroitin sulfate ChondroPlex and anti- bovine inflammatories

Duro-Tuss Children's Herbal respiratory lactoferrin bovine Cough Liquid preparation

Ethical Nutrients Lactobacillus Digestive Inner Health plus acidophilus, Bovine supplements capsules colostrum

Ethical nutrients Lactobacillus Digestive inner health plus acidophilus, Bovine supplements powder colostrum

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Product name Generic name Therapeutic class Comment

Plasma volume Gelatin derived from Gelofusine Gelatin succinylated expander bovine material

Plasma volume Bovine Lactoferrin Haemaccel Polygeline expander Cow’s milk protein

Digestive Immune-5 supplements and cholelitholytics

Inner Health Plus Digestive capsules and Inner supplements and Bovine colostrum Health powder cholelitholytics

Should not be administered to individuals who have Inactivated Japanese previously Jespect Vaccine encephalitis vaccine experienced a serious reaction to bovine serum albumin

Herbal and other Lactoferrin Enhanced complementary Lactoferrin (bovine) & Lactoferrin Plus SB medicines

Methylpred, 40 mg strength Methylprednisolone Methylprednisolone Adrenal steroid includes lactose Alphapharm & Solu- sodium succinate hormones from cow's milk Medrol

Measles, mumps and This product may M-M-R II rubella virus vaccine Vaccine contain residual live foetal bovine serum

contains trace Eptacog alfa amounts bovine IgG NovoSeven RT Haemostatic agents (activated) protein and other bovine proteins

Measles, Mumps, contains residual Rubella and Varicella ProQuad components bovine (Oka/Merck) Virus serum albumin Vaccine Live

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Product name Generic name Therapeutic class Comment

Pertussis vaccine acellular, diphtheria and tetanus toxoids bovine serum Quadracel (adsorbed), albumin inactivated poliovirus types 1, 2 and 3

contains trace amounts of mouse, Recombinate Octocog alfa hamster and bovine protein

pulmonary Survanta Beractant bovine lung extract surfactant

Use with caution in patients previously Thyrogen Thyrotropin alfa Diagnostic Agents treated with bovine TSH

Aprotinin - Factor XIII Use with caution in Tisseel VH S/D - Fibrinogen, Calcium patients with Haemostatic agent Solution chloride dihydrate - allergies to bovine Thrombin proteins

Herbal analgesics Totally Natural chondroitin sulfate and anti- Products Exit Pain (bovine) inflammatories

Travelan Bovine colostrum Anti-diarrhoeal

VAQTA & VAQTA Hepatitis A virus bovine albumin Paediatric/adolescent

Inactive components Varicella zoster include hydrolysed Varivax Vaccines vaccine, live gelatin and traces of bovine serum.

Hepatitis A vaccine; Bovine serum Vivaxim Salmonella typhi Vaccines albumin <10 ng vaccine (Inactive component)

Oral Typhoid Vaccine gelatin (bovine Vivotif Oral Salmonella typhi derived) strain Ty21a

Live varicella Zostavax bovine calf serum vaccine.

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Bovine – Manufacture includes exposure to bovine materials “Bovine-Indirect

Product name Generic name Therapeutic class Comment

Pertussis vaccine, Diphtheria toxoid, Adacel Vaccine Tetanus toxoid, Poliomyelitis vaccine

Acellular pertussis, diphtheria, tetanus Adacel Polio Vaccines and poliovirus type 1, 2 and 3

Avaxim Hepatitis A vaccine Vaccine

Diphtheria toxoid, Boostrix Tetanus toxoid, Vaccine Pertussis vaccine

Diphtheria toxoid, Boostrix – IPV Tetanus toxoid, suspension for Vaccine Pertussis vaccine, injection Poliomyelitis vaccine

Engerix-B Adult and Hepatitis B vaccine Vaccine Paediatric

Havrix 1440 Hepatitis A vaccine Vaccine

Havrix Junior Hepatitis A vaccine Vaccine

Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hexaxim Vaccine Haemophilus influenzae type b conjugate vaccine

Haemophilus B Hiberix Vaccine conjugate vaccine

Diphtheria, tetanus, Infanrix acellular pertussis Vaccine (DTPa) vaccine

Diphtheria, tetanus, acellular pertussis Infanrix-IPV (DTPa) and Vaccine inactivated poliovirus vaccine

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Product name Generic name Therapeutic class Comment

Poliovirus Ipol Vaccine (inactivated)

Merieux inactivated Rabies vaccine Vaccine rabies vaccine

Measles, mumps and This product may M-M-R II rubella virus vaccine Vaccine contain residual live foetal bovine serum

Meningococcal group NeisVac-C Vaccine C polysaccharide Vaccines conjugate vaccine

Pneumococcal Pneumovax 23 purified capsular Vaccine polysaccharides

Measles, mumps & Priorix Vaccines rubella vaccine

Varicella zoster vaccine, Rubella Priorix-tetra vaccine, Mumps Vaccines vaccine, Measles vaccine

Measles, Mumps, contains residual Rubella and Varicella components of ProQuad Vaccines (Oka/Merck) Virus bovine serum Vaccine Live albumin

Pertussis vaccine acellular, diphtheria and tetanus toxoids bovine serum Quadracel (adsorbed), Vaccines albumin inactivated poliovirus types 1, 2 and 3

contraindicated in subjects with a known severe Rabipur Rabies vaccine Vaccines hypersensitivity to chicken eggs, chicken protein, bovine gelatin

Human Rotavirus Rotarix Oral Liquid (live attenuated oral Vaccines vaccine)

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Product name Generic name Therapeutic class Comment

RotaTeq Rotavirus vaccine Vaccines

prepared from genetically engineered Somatropin (rmc), mammalian cells Saizen & Saizen 3 recombinant human Pituitary hormones (recombinant mouse cells - C127) transformed with a bovine papilloma virus vector

Stamaril Yellow Vaccine Vaccines

Pertussis vaccine- acellular, combined Tripacel Vaccines with diphtheria and tetanus toxoids

Combined hepatitis A Twinrix & Twinrix and hepatitis B Vaccines Junior vaccine

Salmonella typhi Vi Typhim Vi polysaccharide Vaccines vaccine

Varilrix HSA-Free Live varicella vaccine Vaccines

Inactive components Varicella zoster include hydrolysed Varivax Vaccines vaccine, live gelatin and traces of bovine serum.

Influenza virus Fluarix Vaccine vaccine

ADT Booster Diphtheria toxoid Vaccine

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Appendix C Chinese Hamster Ovary (CHO) cells

Product name Generic name Therapeutic class Comment

contraindicated in patients with: Actemra Tocilizumab Immunomodifiers known hypersensitivity to any CHO products

Brentuximab Adcetris Antineoplastic vedotin

Advate Octocog alfa Haemostatic agent

Rurioctocog alfa derived from octocog alfa Adynovate Haemostatic agent pegol (Advate)

fully humanised monoclonal Antimigraine Ajovy produced in CHO preparations cells

Enzyme genetically engineered Aldurazyme Laronidase replacement Chinese hamster ovary cell therapy line

Aranesp Darbepoietin Haemopoietic agent produced in CHO cells

produced by recombinant DNA technology in a CHO Avastin Antineoplastic mammalian cell expression system

produced by mammalian Avonex Interferon beta-1a Immunomodifier (CHO) cells

Bavencio . Antineoplastic produced in CHO cells

Bemfola Follitropin alfa (rch) Pituitary hormone produced by a CHO cell

contraindicated in patients BeneFIX Nonacog alfa Haemostatic agent with previous allergy to hamster protein

Inotuzumab Besponsa Antineoplastic ozogamicin (rch)

Blincyto Blinatumomab (rch) Antineoplastic

Antirheumatoid Brenzys Etanercept. agents

Endocrine and Brineura Cerliponase alfa. metabolic agents

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Product name Generic name Therapeutic class Comment

Based on Chinese hamster Mycophenolate CellCept Immunomodifiers inosine-5'-monophosphate mofetil. dehydrogenase

Enzyme Cerezyme Imiglucerase replacement therapy

Cosentyx Secukinumab (rch) Immunomodifier

Darzalex Daratumumab Antineoplastic

Dupixent Dupilumab (rch) Immunomodifier

Elonva Corifollitropin alfa Pituitary hormones

Emgality Antimigraine

Enbrel Etanercept Immunomodifier

Entyvio Vedolizumab Immunomodifier

Eprex Epoietin-alfa Haemopoietic agent

Ophthalmic Eylea Aflibercept medication

Enzyme Fabrazyme Agalsidase beta replacement therapy

Fasenra Benralizumab Immunomodifier

Gonal-f Follitropin alfa Pituitary hormone

expressed in a mammalian Granocyte Lenograstim Supportive therapy host cell system, (CHO) cells

Hemlibra Emicizumab Haemostatic agent

contraindicated in patients Herceptin Trastuzumab Antineoplastic agent with known hypersensitivity to CHO cell proteins

Normal immunoglobulin The vorhyaluronidase alfa.is Hyqvia (human) with Immunoglobulin produced from CHO cells vorhyaluronidase alfa

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Product name Generic name Therapeutic class Comment

Ilumya Tildrakizumab (rch) Immunomodifier

Trastuzumab Kadcyla Antineoplastic agent emtansine.

Kanjinti Trastuzumab Antineoplastic agent biosimilar to Herceptin.

Pembrolizumab Keytruda Antineoplastic agent (rch)

Trace amounts of mouse and Kogenate FS Octocog alfa Haemostatic agent hamster protein present

Lemtrada Alemtuzumab (rch) Immunomodifier

Luveris 75 IU Lutropin alfa Pituitary hormone

Mabcampath Alemtuzumab Antineoplastic agent

Mabthera Rituximab Antineoplastic agent

Metalyse Tenecteplase Fibrinolytic agent

Methoxy Recombinant DNA Mircera polyethylene glycol- Haemopoietic agent technology in CHO cells epoetin beta

Based on Chinese hamster MycoCept Mycophenolate Immunomodifiers inosine-5'-monophosphate dehydrogenase

Endocrine and Myozyme Alglucosidase alfa. metabolic agents

Endocrine and Naglazyme Galsulfase (rch) metabolic agent

NeoRecormon Epoietin beta Haemopoietic agent

Novicrit Epoetin lambda Haemopoietic agent Purified from a CHO cell

NovoSeven RT Eptacog alfa Haemostatic agent Baby hamster kidney cells

Nucala Mepolizumab Respiratory agent

Obizur Susoctocog alfa Haemostatic agent Baby hamster kidney cells

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Product name Generic name Therapeutic class Comment

contraindicated in patients Ogivri Trastuzumab. Antineoplastic agent with hypersensitivity Chinese hamster ovary cell proteins

biosimilar medicine to Ontruzant Trastuzumab. Antineoplastic agent Herceptin

Opdivo Nivolumab Antineoplastic agent

Recombinant DNA Orencia Abatacept Immunomodifier technology in CHO cells

Choriogonadotropin Ovidrel Pituitary hormone alfa

Follitropin alfa Pergoveris (rch)/lutropin alfa Pituitary hormone (rch)

contraindicated in patients with hypersensitivity to Perjeta Pertuzumab Antineoplastic agent Chinese hamster ovary cell proteins

Hypolipidaemic Praluent (rch) agent

Affects calcium and Prolia bone metabolism

contraindicated in patients Pulmozyme Dornase alfa Respiratory agent who have hypersensitivity to Chinese hamster ovary cell

Puregon Follitropin beta Pituitary hormone

Rebif Interferon beta-1a Immunomodifier

Recombinate Recombinate antihaemophilic Haemostatic agent factor

Rekovelle Follitropin delta Pituitary hormone

Hypolipidaemic Repatha agent

Recombinant contraindicated in patients Factor Rixubis Haemostatic agent with known hypersensitivity IX (rFIX), Nonacog hamster protein gamma (rch)

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Product name Generic name Therapeutic class Comment

Endocrine and Strensiq Asfotase alfa rch metabolic agent

Sylvant siltuximab (rmc) Antineoplastic agent

Thyrogen Thyrotrophin alfa Diagnostic agent

Antineoplastic Trazimera Trastuzumab biosimilar to Herceptin agents

Antineoplastic Recombinant DNA Vectibix Panitumumab agents technology in CHO cells

Endocrine and Vimizim Elosulfase alfa (rch) metabolic agent

Xgeva Denosumab Antineoplastic agent

Xolair Omalizumab Respiratory agent

contraindicated in patients with a known history of Xyntha Haemostatic agent hypersensitivity to hamster proteins

Yervoy Ipilimumab Antineoplastic agent

Antibiotics and anti- Zinplava infective

Appendix D - Murine (mouse)

Product name Generic name Therapeutic class Comment

contains trace amounts of mouse immunoglobulin G Advate Octocog alfa Haemostatic agent Contraindicated in known hypersensitivity to mouse proteins

Rurioctocog alfa derived from octocog alfa Adynovate Haemostatic agent pegol (Advate)

produced in a recombinant Arzerra Ofatumumab Antineoplastic agent murine cell line

Humanised murine Avastin Bevacizumab Antineoplastic agent antibody

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Product name Generic name Therapeutic class Comment

Anticoagulant, may contain traces of Ceprotin Protein C antithrombotic mouse protein

produced in murine (NS0) Cyramza Antineoplastic agent cells

consists of regions of Empliciti Elotuzumab Antineoplastic agent mouse antibody grafted onto human IgG1

produced in mammalian cell culture by mouse Erbitux Antineoplastic agent myeloma cells (Sp2/0)

contraindicated in patients with known Gazyva Obinutuzumab Antineoplastic agent hypersensitivity to murine proteins

Murine anti-p185 HER2 Herceptin Trastuzumab Antineoplastic agent antibody

biosimilar to Remicade should not be given to Inflectra Infliximab Immunomodifier patients with a history of hypersensitivity to murine proteins

Kanjinti Trastuzumab Antineoplastic agent Biosimilar to Herceptin

Trace amounts of mouse Kogenate Octocog alfa Haemostatic agent protein are present

contains a murine single Kymriah Tisagenlecleucel Antineoplastic agent chain antibody fragment

humanised with regions from Lemtrada Alemtuzumab Immunomodifier a murine monoclonal antibody

Immunoglobulin G1, with Ophthalmic Lucentis human-mouse monoclonal medication rhuFab V2 κ-chain

contraindicated in patients with a known MabCampath Alemtuzumab Immunomodifier hypersensitivity to murine proteins

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Product name Generic name Therapeutic class Comment

Genetically engineered Mabthera Rituximab Antineoplastic agent chimeric murine/human monoclonal antibody

contains trace amounts of NovoSeven RT Eptacog alfa Haemostatic agent mouse IgG protein

Ogivri Trastuzumab Antineoplastic agent Biosimilar to Herceptin

Ontruzant Trastuzumab Antineoplastic agent Biosimilar to Herceptin

humanised monoclonal Detoxifying agent, antibody derived from Praxbind murine IgG1 isotype antibody molecule

contains trace amounts of Recombinate Octocog alfa Haemostatic agent mouse protein

Monoclonal antibody composed of human Remicade Infliximab Immunomodifier constant and murine variable regions

biosimilar medicine to Renflexis Infliximab Immunomodifier Remicade

biosimilar medicine to Riximyo Rituximab Antineoplastic agent Mabthera

prepared from genetically engineered mammalian Saizen Somatropin Pituitary hormone cells (recombinant mouse cells

Simponi Murine hybridoma cell line prefilled Golimumab Antirheumatoid agent with recombinant DNA syringe technology solution

Murine/human chimeric Simulect Basiliximab Immunomodifier monoclonal antibody

Human/murine hybrid monoclonal antibody Soliris Eculizumab Immunomodifier produced by murine myeloma cell culture

chimeric human murine Sylvant siltuximab Antineoplastic agent monoclonal antibody

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Product name Generic name Therapeutic class Comment

5% murine amino acid Synagis Immunomodifier sequences

Trazimera Trastuzumab Antineoplastic agent Biosimilar to Herceptin

Human/murine hybrid monoclonal antibody Tysabri Natalizumab Immunomodifier produced in murine myeloma cells

recombinant monoclonal antibody that contains Xolair Omalizumab Respiratory agent regions of a humanised murine antibody

patient's own T cells are harvested and genetically modified ex vivo by axicabtagene retroviral transduction to Yescarta Antineoplastic agent ciloleucel express a chimeric receptor (CAR) comprising a murine anti-CD19 single chain variable fragment

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Appendix E - Equine (Horse)

Therapeutic Product name Generic name Comment class

Equine Antithymocyte ATGAM Immunomodifier globulin

Black Black snake Antivenom antivenom

Brown snake Brown Antivenom antivenom

Death adder Death adder antivenom Antivenom antivenom

Conjugated Duavive Gonadal hormone estrogens/bazedoxifene.

Brown snake antivenom, Death adder antivenom, Polyvalent snake Antivenom antivenom, antivenom antivenom, antivenom

Premarin Oestrogens, Conjugated Gonadal hormone tablets

Red back Red back spider Antivenom antivenom antivenom

Sea snake antivenom Antivenom antivenom

Stonefish Stonefish antivenom Antivenom antivenom

Human fibrinogen and Surgical TachoSil equine collagen human thrombin Preparation

Taipan Taipan antivenom Antivenom antivenom

Tiger snake Tiger snake antivenom Antivenom antivenom

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Appendix F - Egg/Chicken

Product name Generic name Therapeutic use Comment

manufactured in eggs. trace amounts of quadrivalent Afluria Quad Vaccine ovalbumin (< 1 influenza vaccine microgram/0.5 mL dose), may be present

Influenza virus vaccine may contain egg, Agrippal Vaccine vaccine chicken

Contraindicated in patients with known Antihypertensive Cleviprex Clevidipine allergies to eggs or egg agent products as contains egg lecithin

Contraindicated in Parenteral vitamins, patients with known ClinOleic 20% Olive oil and soya oil minerals and hypersensitivity to egg as nutrition contains egg lecithin

Diprivan Anaesthetics Contains egg lecithin

prepared using whole Influenza virus Fluarix Vaccine virus cultivated in vaccine embryonated hen eggs

grown in hens' eggs Influenza virus May also contain chicken Fluad Vaccine vaccine proteins (such as ovalbumin0

quadrivalent Fluad Quad Vaccine grown in hens' eggs influenza vaccine

Quadrivalent propagated in chicken FluQuadri Vaccine Influenza Vaccine eggs

Fluzone High- trivalent influenza propagated in chicken Vaccine Dose vaccine eggs

Fresofol 1% Injection & Propofol Anaesthetics Contains egg lecithin Fresofol 1% MCT/LCT

prepared from virus Influenza virus grown in the allantoic Influvac Vaccine vaccine cavity of embryonated eggs

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Product name Generic name Therapeutic use Comment

Parenteral vitamins, Intralipid Soya oil minerals and Contains egg lecithin nutrition

Parenteral vitamins, Kabiven G11% & minerals and Contains egg lecithin Kabiven G19% nutrition

Contraindicated in endocrine and patients with Kanuma Sebelipase alfa metabolic agent hypersensitivity to egg as produced in egg white

Measles, mumps and produced in chick embryo M-M-R II Vaccine rubella virus vaccine l cell culture

Parenteral vitamins, Olimel, minerals and contains egg lecithin PeriOlimel nutrition

produced in chick embryo Measles, mumps and Priorix Vaccine cell culture, may contain rubella virus vaccine traces of egg protein

Measles, mumps, produced in chick embryo Priorix-Tetra & rubella and varicella Vaccine cell culture, may contain ProQuad vaccine traces of egg protein

Propofol Sandoz Propofol-Lipuro 1%/2% Propofol Anaesthetics Contains egg lecithin Provive 1% and Provive MCT-LCT 1%

grown in the yolk sacs of Q-Vax & Q-Vax Coxiella burnetii embryonated eggs. Trace Vaccine Skin Test vaccine amounts of ovalbumin may also be present

Made from purified chick Rabipur Rabies vaccine Vaccine embryo cell

Rixadone Risperidone Antipsychotic agent Contains Egg products

propagated in chick Stamaril Yellow Fever Vaccine Vaccine embryos

SmofKabiven Parenteral vitamins, Contains egg Electrolyte Free minerals and phospholipids and Fish & SmofKabiven nutrition oil

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Product name Generic name Therapeutic use Comment

Parenteral vitamins, Contains egg lecithin and SMOFlipid minerals and fish oil nutrition

prepared from virus Influenza virus grown in the allantoic Vaxigrip Vaccine vaccine cavity of embryonated eggs

Contains egg ophthalmic Visudyne Verteporfin phosphatidylglycerol medication sodium

Parenteral vitamins, Vitalipid N minerals and Contains egg lecithin nutrition

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Appendix G – Other Animals

Product name Generic name Therapeutic uses Comment

house dust mite Antiallergy Acarizax Contains gelatin (fish) extract preparation

Box Jellyfish from the plasma of antivenom Antivenom Antivenom sheep

Complementary From bovine or shark Chondroitin Chondroitin osteoarthritis cartilage

Digoxin binding antibody DigiFab Antidote From sheep Digoxin-specific antibody fragment

contains the oil Inactivated squalene which is Fluad Vaccine influenza vaccine obtained from shark liver

Funnel Web Spider Funnel web spider prepared from the antivenom Antivenom antivenom (rabbit) plasma of rabbits

Complementary Glucosamine Glucosamine From shellfish osteoarthritis

Antiallergy Grazax Phleum pratense. contains gelatine (fish) preparation

Human (rys) Contain protamine Protaphane Insulin Insulin preparation sulfate (a fish product) Mixtard 30/70. Mixtard 50/50

Mammalian cells (Not Humira Adalimumab Immunomodifier specified)

Mono-plus mononucleosis Diagnostic Guinea pig, horse test

Baby hamster kidney Novoseven Eptacog alfa Haemostatic agent (BHK) cells

Eicosapentaenoic acid (EPA) ethyl obtained by the ester, transesterification of Omacor cardiovascular agent docosahexaenoic the body oil of fat fish acid (DHA) ethyl species ester.

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Product name Generic name Therapeutic uses Comment

Protamine Sulfate Caution in patients Haemostatic agent Injection allergic to fish

Parenteral vitamins, Contains egg lecithin SMOFlipid minerals and and fish oil nutrition

Antithymocyte Thymoglobuline Immunomodifier Rabbit globulin (rabbit)

Compiled from reference 9

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Appendix H - Excipients that may be of animal origin

Product Source

Gathered by bees and collected from legs of Bee pollen bees

From the exoskeletons of arthropods and Chitin crustacean

Chymotrypsin Cochineal/Carmine/Carminic Ox pancreas acid

Cochineal/carmine/carmininc acid Red pigment from crushed cochineal insects

Disodium inosinate From meat extract

From pig skin, bovine hide and pork and cattle Gelatin bones. Used for many capsules

Glycerol May be derived from animal fats

From cows’ milk (by-product of dairy Lactose industry). Usually made synthetically (Common filler in tablets)

Lanolin Fat extracted from sheep’s wool

Oleic oil and oleostearin From pressed tallow

Propolis Bee glue

Shellac Insect secretion

Fat from cows, sheep, dogs or cats. Stearic acid Can be obtained from vegetable sources

Trypsin Enzyme from pork pancreas

Compiled from references 11, 12

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7 References

1. Reproduced with permission from Partnering with patients in their own care, developed by the Australian Commission on Safety and Quality in Health Care (ACSQHC). ACSQHC: Sydney

2. United Kingdom. National Prescribing Centre. Task Force on Medicines Partnership. Drugs of porcine origin and their clinical alternatives. An introductory guide. March 2004 [11 December 2007] Available from: http://archive.mcb.org.uk/wp- content/uploads/2015/12/Drugs-Derived-From-Pigs-and-their-Clinical- Alternatives_Booklet.pdf

3. Eldred BE, Dean AJ, McGuire TM, Nash AL. Vaccine components and constituents: responding to consumer concerns. MJA 2006;184 (4):170-175. 4. Rodger, D., Blackshaw, B.P. Using animal-derived constituents in anaesthesia and surgery: the case for disclosing to patients. BMC Med Ethics 20, 14 (2019. Available at https://doi.org/10.1186/s12910-019-0351-4 5. Alberta Health Services – Calgary. Medications derived from animals and culturally diverse patients. 2nd edition. Available at https://www.albertahealthservices.ca/assets/programs/ps-1026227-health-care-religious- beliefs.pdf 6. National Prescribing Services (NPS). Pharmaceutical excipients – where do we begin? 1 August 2011 DOI: 10.18773/austprescr.2011.060 7. What are excipients doing in medicinal products? Drug and Therapeutics Bulletin 2009;47:81-84. http://dx.doi.org/10.1136/dtb.2009.06.0026 8. United States. Immunization Action Coalition. World Health Organisation Regional Office for the Eastern Mediterranean - The use of unlawful or juridically unclean substances in food and medicine (correspondence dated 17 July 2001). [27 June 2007] Available from: www.immunize.org/concerns/porcine.pdf 9. MIMS Online. Retrieved from http://www.mims.com.au 10. Australian Register of Therapeutic Goods (ARTG). Therapeutic Goods Administration. Department of Health and Ageing. Australian Government available from http://www.tga.gov.au/industry/artg.htm 11. Sriaandhal Sabalingam1, W. J. A. Banukie N. Jayasuriya. Pharmaceutical Excipients of Marine and Animal origin: A Review Biological and Chemical Research (ISSN 2312-0088), Vol.6, 184-196 12. Alamgir A.N.M. (2018) Bioactive Compounds and Pharmaceutical Excipients Derived from Animals, Marine Organisms, Microorganisms, Minerals, Synthesized Compounds, and Pharmaceutical Drugs. In: Therapeutic Use of Medicinal Plants and their Extracts: Volume 2. Progress in Drug Research, vol 74. Springer, Cham. https://doi.org/10.1007/978-3-319-92387-1 _4 13 The Vegan society (England and Wales) Is my medication vegan? available at: https://www.vegansociety.com/whats-new/blog/my-medication-vegan

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8 Approval

Approving Officer: Justin Lee Director Medication Services Queensland 2020

9 Version Control

Version Amendments Author/s Approved

Supersedes original version published in 2.0 A Jagels November 2013 2007

Fixed broken link to booklet on porcine 2.1 A Jagels April 2019 medicines. Updated organisational details

J Quin 3.0 Review November 2020 A Jagels

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